FDA Restricts Use Of Two Antibody Drugs That Don’t Work Against Omicron

AP: FDA Halts Use Of Antibody Drugs That Don't Work Vs. Omicron
COVID-19 antibody drugs from Regeneron and Eli Lilly should no longer be used because they don’t work against the omicron variant that now accounts for nearly all U.S. infections, U.S. health regulators said Monday. The Food and Drug Administration said it was revoking emergency authorization for both drugs, which were purchased by the federal government and have been administered to millions of Americans with COVID-19. If the drugs prove effective against future variants, the FDA said it could reauthorize their use. (Perrone, 1/24)

The Hill: Biden Administration Limits Use Of Two Monoclonal Antibody Treatments
The agency said the therapies made by Eli Lilly and Regeneron should only be used in patients that have been infected with or exposed to a variant that is susceptible to the treatments.  "Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time," the FDA said. (Weixel, 1/24)

The Washington Post: FDA Ends For Now Use Of Two Monoclonal Antibodies, Spurring A Halt In Federal Shipments Of The Covid-19 Treatments - The Washington Post
As a result, the Department of Health and Human Services, which distributes covid treatments to states, notified state health officials that it has halted distribution of the antibody medications made by Regeneron Pharmaceuticals and Eli Lilly, according to an email sent to the states and obtained by The Washington Post. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement that data show the two antibody treatments “are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States.” Omicron is responsible for more than 99 percent of cases in the United States, according to the Centers for Disease Control and Prevention. (McGinley, 1/24)

In related news from Florida and Maine —

CNN: Florida Shuts Down All Monoclonal Antibody Treatment Sites After FDA Decision To Limit Use Of Certain Treatments Not Proven Effective Against Omicron
Florida is closing its monoclonal antibody treatment sites, health officials announced late Monday, citing the US Food and Drug Administration's decision to limit the use of certain versions of the treatments that were found less effective against the now-dominant Omicron variant of coronavirus. "Unfortunately, as a result of this abrupt decision made by the federal government, all monoclonal antibody state sites will be closed until further notice," the Florida Department of Health said in a statement. More than 2,000 appointments for the treatment were canceled in the state on Tuesday alone, according to a statement from Gov. Ron DeSantis. (Boyette, 1/25)

Bangor Daily News: Maine’s Supply Of Omicron Treatment Will Almost Double After State Demands More From Feds
Maine’s weekly allocation of a drug vital to treating the omicron variant of COVID-19 will nearly double after Gov. Janet Mills asked the federal government for more of the life-saving drug. Maine will receive 120 doses of the monoclonal antibody sotrovimab, the only available monoclonal antibody known to fight off infections from the omicron variant, this week instead of the previously allocated 66, Mills’ office said Monday. The increase in doses came after Mills reached out to White House Coronavirus Response Coordinator Jeff Zients over the weekend. She told him that Maine was not receiving an adequate number of doses for the cases it was seeing, her office said. (Marino Jr., 1/24)